Index of drugs

Treatment of symptoms of nasal edema and fever and pain associated with common cold in adults and adolescents from 16 years of age.

1 sachet contains 500 mg of Acetylsalicylic acid (ASA) and 30 mg of pseudoephedrine hydrochloride; the drug contains sucrose.

Acetylsalicylic acid (ASA) belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). Irreversibly inhibits arachidonic acid cyclooxygenase, inhibiting the synthesis of prostanoids: prostaglandin E2 (PGE2), prostaglandins I2 (PGI2) and thromboxane A2. By inhibiting the synthesis of thromboxane A2 in platelets, ASA also inhibits platelet aggregation. Pseudoephedrine (the dextrorotatory ephedrine isomer) is an α-adrenomimetic. By stimulating the α-adrenergic receptors of the vascular smooth muscle, it causes the dilated arterioles to contract in the nasal mucous membrane and reduces the blood flow to the bloodshot area. After oral administration, ASA is absorbed quickly and completely from the gastrointestinal tract. During absorption and after absorption, it is transformed into the main metabolite - salicylic acid. The maximum concentration of ASA in the blood is reached after 10-20 minutes, and salicylic acid after 0.3-2 hours. Both ASA and salicylic acid bind strongly to plasma proteins. Salicylic acid crosses the placenta and into breast milk. It is metabolised mainly in the liver. The main metabolites are salicylic acid coupled with Glycine (salicylic acid), ether and glucuronic acid ester of salicylic acid, and gentisic acid in free form and conjugated with glycine. The kinetics of elimination of salicylic acid depend to a large extent on the dose, because the metabolism of salicylic acid is limited by the activity of liver enzymes. T_0,5 is 2-3 hours after using small doses (up to 325 mg / day), up to about 15 hours after high therapeutic doses (> 3 g / day) or in the case of poisoning. Salicylic acid and its metabolites are mainly excreted by the kidneys. Pseudoephedrine is rapidly absorbed from the gastrointestinal tract, reaching C_max after 20-120 minutes It penetrates into breast milk. In 70-90% it is excreted unchanged in urine. It is partially metabolised in the liver, the main active metabolite is norpseudoephedrine (in healthy people excreted in urine in about 1%, while it can account for about 6% in patients with chronic urine alkalization). T_0,5 pseudoeperidin is 5-6 h at pH 5-6; in the case of long-term alkalinisation of urine, it may be 50 hours; in the case of very acidified urine - 1.5 h. Conventional hemodialysis shows only minimal effectiveness in removing pseudoephedrine from the body.

Hypersensitivity to Acetylsalicylic acid, other salicylates, to pseudoephedrine or to any of the excipients. A positive history of bronchial asthma induced with salicylates or substances with similar effects, especially NSAIDs. Active ulceration of the digestive tract. Hemorrhagic diathesis. Severe hepatic failure. Severe renal failure. Severe heart failure. Severe hypertension. Severe coronary heart disease. Methotrexate doses ≥ 15 mg / week. The use of MAO inhibitors in the previous 2 weeks. Pregnancy and breastfeeding.

Very frequent use of analgesics (especially several different analgesics at the same time) can cause permanent kidney damage (analgesic nephropathy). The drug should be used with caution in patients with: renal impairment or cardiovascular disorders such as renal vascular disease, congestive heart failure, hypovolaemia, major surgery, sepsis or major haemorrhagic events (ASA may further increase the risk of renal dysfunction or acute renal failure) renal function); with hepatic impairment; with a history of gastrointestinal ulceration, including chronic or recurrent peptic ulcer disease, or history of gastrointestinal bleeding; with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps and patients with allergic reactions (e.g.skin reactions, pruritis, urticaria) to other substances, in particular to non-steroidal anti-inflammatory and anti-rheumatic drugs (risk of bronchospasm, asthma attack or other hypersensitivity reactions); during concomitant use of anticoagulants and after surgical procedures, including minor procedures, e.g. tooth extraction (prolonged bleeding time, due to the anti-aggregation effect of ASA); with reduced uric acid excretion (risk of gout attack); deficient in glucose-6-phosphate dehydrogenase (risk of haemolysis or haemolytic anemia), factors that increase this risk are eg high doses of ASA, fever and acute infections); with hyperthyroidism, mild or moderate hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, prostatic hyperplasia and hypersensitivity to sympathomimetic drugs; in the elderly (increased sensitivity to the effects of pseudoephedrine on the CNS). Due to the sucrose content, the drug should not be used in patients with rare hereditary disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. The content of sucrose (2 g in 1 sash - the amount corresponding to 0.17 carbohydrate exchanger) should be taken into account in patients with diabetes mellitus. Do not use in children <16 years of age, due to the risk of Reye's syndrome.

The preparation is contraindicated in pregnancy and breast-feeding.

ASA. Abdominal pain, dyspepsia, gastritis, nausea, vomiting, diarrhea, gastrointestinal ulcers (which may in some cases lead to gastrointestinal perforation), transient liver dysfunction accompanied by elevated transaminases, dizziness and tinnitus (which may be symptoms overdose), renal dysfunction, acute renal failure, hemolysis and haemolytic anemia in patients with severe forms of glucose-6-phosphate dehydrogenase, bleeding (eg, in the perioperative period, hematomas, epistaxis, urogenital tract, gums ) - bleeding can lead to acute or chronic iron deficiency anemia (eg in the course of occult bleeding) with accompanying laboratory and clinical symptoms, such as weakness, pallor of skin layers and symptoms of organ hypoperfusion; hypersensitivity reactions with laboratory and clinical symptoms including: asthmatic syndrome, mild or moderate reactions that may include skin, respiratory tract, gastrointestinal tract and cardiovascular system, including rash, urticaria, edema, pruritus, rhinitis, hyperemia and nasal congestion , heart and respiratory failure and, in very rare cases - severe reactions, including anaphylactic shock.pseudoephedrine. Increase in blood pressure (but not in the case of controlled hypertension), various cardiac symptoms (eg tachycardia, palpitations, arrhythmias), CNS stimulation (eg insomnia, in rare cases of hallucinations), urinary retention (especially in patients with prostatic hyperplasia), skin symptoms (eg rash, urticaria, pruritus).

Orally. Disposable contents of 1-2 sachets. If necessary, the single dose can be repeated at intervals of 4-8 hours. The maximum daily dose is 6 sachets. The drug should not be used for more than 3 days (without consulting a doctor). If one of the symptoms dominates, it is more appropriate to use a single-component formulation.Way of giving. The contents of the sachet should be dissolved in a glass of water.